The Role of Pulsatile Insulin Secretion (A Study Investigating the Effects of Partial Pacreatectomy on Glucose Metabolism) (Pilot OGTT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00841867
First received: February 10, 2009
Last updated: June 21, 2010
Last verified: August 2009
  Purpose

The purpose of this study is to examine changes in sugar metabolism that may occur in subjects who have previously had part of their pancreas removed due to a benign lesion.


Condition Intervention
Impaired Glucose Tolerance
Procedure: All subjects will undergo a 120 minute Oral Glucose Tolerance Test at study visit 2.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Pilot Study Investigating the Effects of Partial Pancreatectomy on Glucose Tolerance

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • To determine differences in glucose metabolism between subjects who have had partial pancreatectomy due to a benign lesion and those who have not had such a surgery. [ Time Frame: Outcome will be determined after all data has been collected. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects 18-80 years of age who have previously undergone partial pancreatectomy due to a benign lesion
Procedure: All subjects will undergo a 120 minute Oral Glucose Tolerance Test at study visit 2.
All subjects will ingest a 75 g glucose solution (Glucola brand) and have blood drawn at 7 timepoints over 120 minutes.
Placebo Comparator: 2
Healthy control subjects, 18-80 years of age, who have not had partial pancreatectomy.
Procedure: All subjects will undergo a 120 minute Oral Glucose Tolerance Test at study visit 2.
All subjects will ingest a 75 g glucose solution (Glucola brand) and have blood drawn at 7 timepoints over 120 minutes.

Detailed Description:

Beta cells of the pancreas are the insulin producing cells. People with impaired fasting glucose have a beta cell mass ~50% of that of normal glucose tolerant subjects.

A 2006 canine study by Dr. Peter Butler's group at UCLA demonstrated that glucose stimulated insulin secretion was deficient after 50% decrease in beta cell mass after distal pancreatectomy compared to those dogs who had sham surgery. The pancreatectomized dogs had impaired fasting glucose with impaired insulin secretion and insulin resistance. The decreased insulin secretion was a result of decreased insulin secretory pulses or bursts with no change seen in pulse frequency, the same pattern seen in humans with Type 2 diabetes. Conclusions derived from this study include the following:

  1. When beta cell mass declines to ~50% the capacity for the remaining beta cells to secrete insulin in appropriate secretory bursts is compromised, leading to a deficit in insulin secretion most obvious on glucose stimulation.
  2. The decreased insulin burst mass results in an additional component of insulin resistance, and this together with the compromised capacity for insulin secretion leads to decompensation of glucose regulation and diabetes onset.

How does this translate in humans who have had partial pancreatectomy? In 1990, Kendall and colleagues published a study looking at the effects of hemipancreatectomy in healthy human subjects on insulin secretion and glucose tolerance. These subjects were donors for pancreatic transplantation. They showed that fasting insulin and c-peptide levels were lower one year after hemipancreatectomy. Seven of the 28 donors had abnormal glucose tolerance one year after hemipancreatectomy, but all 28 had normal fasting plasma glucose levels. This study and others like it confirm the development of impaired glucose tolerance after partial pancreatectomy, but pulsatile insulin secretion and hepatic insulin clearance were not measured.

As stated above, the main objective of this pilot study is to establish and quantify the impact of a deficit in beta cell mass, due to partial pancreatectomy for benign tumors, on glucose tolerance. Results of this study may be used to develop a future metabolic study that uses glucose isotopes to establish the effects of partial pancreatectomy on glucose tolerance, basal and stimulated insulin secretion as well as hepatic and extrahepatic insulin sensitivity under conditions of usual physiology. This will enable us to further understand the relationship between loss of beta cells, decreased insulin secretion and increased insulin resistance in humans.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and Female subjects
  • 18-80 years of age who have had
  • partial pancreatectomy due to a benign lesion
  • OR are healthy control subjects
  • are willing to fast (nothing to eat or drink for 10 hours)prior to visits

Exclusion Criteria:

  • Pancreatic malignancy
  • Chronic pancreatitis
  • Pregnant
  • On steroid medications such as prednisone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841867

Contacts
Contact: Care Felix, BS, CCRC 310-794-5474 cfelix@mednet.ucla.edu

Locations
United States, California
UCLA General Clinical Research Center (GCRC) Recruiting
Los Angeles, California, United States, 90024
Contact: Care Felix, BS, CCRC    310-794-5474      
Sponsors and Collaborators
University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Peter Butler, M.D., Larry Hillblom Islet Research Center, David Geffen School of Medicine at UCLA
ClinicalTrials.gov Identifier: NCT00841867     History of Changes
Other Study ID Numbers: DK61539, R01DK061539
Study First Received: February 10, 2009
Last Updated: June 21, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Impaired Glucose Tolerance
Diabetes

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 27, 2014